Liver TransplantPhase 4NCT00171509
Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
A Phase 4 study testing Cyclosporine microemulsion in people with Liver Transplant, run by Novartis.
Trial summary
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Cyclosporine microemulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Oct 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- At least 6 months post-transplant
- At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
- Receiving stable doses of cyclosporine microemulsion for the past 3 months
Who cannot join
- - Severe rejection within the past 3 months
- Severe kidney dysfunction
- Transplanted for hepatitis C or autoimmune hepatitis
- Other protocol-defined exclusion criteria applied
About this study
Official title: A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.
- Conditions
- Liver Transplant
- Being tested
- Cyclosporine microemulsion
- Keywords
- Liver transplant, adults, once a day administration, Immunosuppressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine microemulsionDrug
| Study group | Role | What they receive |
|---|---|---|
| BID cyclosporine | Active comparator | control group continuing with a BID administration of cyclosporine and C2 monitoring. Receives: Drug: Cyclosporine microemulsion |
| OAD cyclosporine | Experimental | conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion Receives: Drug: Cyclosporine microemulsion |
| OAD cyclosporine reduced | Experimental | OAD administration of cyclosporine with a daily dose adjusted to a reduced C2 Receives: Drug: Cyclosporine microemulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
Secondary outcomes (4)
assess the safety of a once a day administration of cyclosporine microemulsion.
compare for each patient the C2 levels pre- and post-conversion.
characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171509
- Sponsor's protocol ID
- COLO400A2421
- Status last verified
- Jan 2011
- First submitted
- 12 Sep 2005
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT00171509
- Acronym / sponsor ID
- COLO400A2421
- Conditions
- Liver Transplant
- Keywords
- Liver transplant, adults, once a day administration, Immunosuppressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BID cyclosporine | Active comparator | Drug: Cyclosporine microemulsioncontrol group continuing with a BID administration of cyclosporine and C2 monitoring. |
| OAD cyclosporine | Experimental | Drug: Cyclosporine microemulsionconversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion |
| OAD cyclosporine reduced | Experimental | Drug: Cyclosporine microemulsionOAD administration of cyclosporine with a daily dose adjusted to a reduced C2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 6 months post-transplant
- At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
- Receiving stable doses of cyclosporine microemulsion for the past 3 months
Key exclusion criteria (4 listed)
- - Severe rejection within the past 3 months
- Severe kidney dysfunction
- Transplanted for hepatitis C or autoimmune hepatitis
- Other protocol-defined exclusion criteria applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine microemulsion | Drug | BID cyclosporine, OAD cyclosporine, OAD cyclosporine reduced |
Primary outcome
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
4 secondary outcomes
assess the safety of a once a day administration of cyclosporine microemulsion.
compare for each patient the C2 levels pre- and post-conversion.
characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine microemulsion in people with Liver Transplant, run by Novartis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.